A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma

• ClinicalTrials.gov Identifier: NCT05888844
• Recruitment Status: Recruiting
• First Posted: June 5, 2023
• Last Update Posted: May 10, 2024
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Tracking Information

• First Submitted Date: May 24, 2023
• First Posted Date: June 5, 2023
• Last Update Posted Date: May 10, 2024
• Actual Study Start Date: October 9, 2023
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2023)

• Objective response rate (ORR) [ Time Frame: Up to 2 years ]
  Defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), as determined by the blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or composite criteria for metastatic cSCC and per World Health Organization (WHO) criteria for locally advanced cSCC.
• Number of participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years 3 months ]
  Defined as any Adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug or until the start of new anticancer therapy, whichever occurs first.
• Number of participants with TEAEs leading to dose modification or discontinuation [ Time Frame: Up to 2 years ]
  Number of participants with TEAEs leading to dose modification or discontinuation.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 24, 2023)

• Disease Control Rate (DCR) [ Time Frame: Up to 2 years ]
  Defined as the percentage of participants with the best overall response of CR or PR, or stable disease (SD), after a minimum of 15 weeks following the initiation of study treatment as determined by the BICR per RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
• Duration Of Response (DOR) [ Time Frame: Up to 2 years ]
  Defined as the time from the earliest date of confirmed CR or PR to the earliest date of disease progression, as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
• Time to Response (TTR) [ Time Frame: Up to 2 years ]
  Defined as the time from the date of first dose to the earliest date of confirmed CR or PR as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC.
• Progression-free survival (PFS) [ Time Frame: Up to 2 years ]
  Defined as the time from the date of first dose to the earliest date of disease progression as determined by the BICR according to RECIST v1.1 or composite criteria for metastatic cSCC and WHO criteria for locally advanced cSCC or death due to any cause if occurring sooner than progression.
• Overall Survival (OS) [ Time Frame: Up to 2 years ]
  Defined as the time from the date of first dose to death due to any cause.
• INCB099280 pharmacokinetic (PK) in Plasma [ Time Frame: Pre dose and 1, 2 and 6 hours post dose on Cycle 1 Day 1 and Cycle 2 Day 1. Pre dose every other cycle until Cycle 11 Day 1 (Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1 and Cycle 11 Day 1) (each cycle is 28 days) ]
  INCB099280 concentration in plasma

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate INCB099280 in Participants With Advanced Cutaneous Squamous Cell Carcinoma
• Official Title: A Phase 2 Study Evaluating INCB099280 in Participants With Advanced Squamous Cell Carcinoma
• Brief Summary: This study is being conducted to determine the safety, tolerability, and preliminary efficacy of INCB099280 in participants with advanced Cutaneous Squamous Cell Carcinoma.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study consists of 2 parts. In Part 1, participants with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC will be randomized 1:1:1 to INCB099280 Dose 1, Dose 2, or Dose 3. In Part 2, one dose level identified from Part 1 will be expanded to enroll additional participants with metastatic cSCC and locally advanced cSCC.

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Cutaneous Squamous Cell Carcinoma

Intervention

Drug: INCB099280

Administered as specified in the treatment arm description.

Study Arms

• Experimental: Part 1: INCB099280 Dose 1
  Participants will receive INCB099280 dose 1 twice daily (BID) for up to 2 years.
  Intervention: Drug: INCB099280
• Experimental: Part 1: INCB099280 Dose 2
  Participants will receive INCB099280 dose 2 twice daily (BID) for up to 2 years.
  Intervention: Drug: INCB099280
• Experimental: Part 1: INCB099280 Dose 3
  Participants will receive INCB099280 dose 3 twice daily (BID) for up to 2 years.
  Intervention: Drug: INCB099280
• Experimental: Part 2: INCB099280 Dose selected from Part 1
  Participants will receive INCB099280 dose selected from Part 1 twice daily (BID) for up to 2 years.
  Intervention: Drug: INCB099280

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 24, 2023): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2026
• Estimated Primary Completion Date: December 31, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histopathological diagnosis of cSCC.
• Previously untreated or recurrent locally advanced (without nodal metastases) or metastatic (distant or regional metastasis) cSCC not amenable to curative surgery and/or radiotherapy.
• Measurable disease based on either radiographic imaging per RECIST 1.1 or WHO criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Life expectancy > 3 months.
• Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

• Known history of an additional malignancy.
• Central nervous system (CNS) metastases requiring treatment and/or leptomeningeal disease.
• Toxicity from prior therapy that has not recovered.
• Prior receipt of an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent; treatment with an immune modulator (eg, CTLA-4, GITR, LAG3, TIM3, OX40, ICOS, IL-2, 4-1BB, CAR-T cell).
• Received thoracic radiation within 6 months of the first dose of study treatment.
• Participation in another interventional clinical study while receiving INCB099280.
• Impaired cardiac function or clinically significant cardiac disease.
• History or evidence of interstitial lung disease including noninfectious pneumonitis.
• Presence of gastrointestinal conditions that may affect drug absorption.
• Any autoimmune disease requiring systemic treatment in the past 5 years.
• Diagnosis of primary immunodeficiency or receiving chronic systemic steroid therapy at a daily dose exceeding 10 mg of prednisone or equivalent.
• Active infection requiring systemic therapy.
• History of organ transplantation, including allogeneic stem cell transplantation.
• Receipt of systemic antibiotics within 28 days of first dose of study treatment.
• Probiotic usage is prohibited during screening and throughout the study treatment period.
• Received a live vaccine within 28 days of the planned start of study drug.
• Laboratory values outside the Protocol-defined ranges.
• Inadequate organ function.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Incyte Corporation Call Center (US); 1.855.463.3463; medinfo@incyte.com

Contact: Incyte Corporation Call Center (ex-US); +800 00027423; eumedinfo@incyte.com

• Listed Location Countries: Australia, Brazil, Canada, Chile, Colombia, Croatia, Finland, France, Hungary, Korea, Republic of, Mexico, Montenegro, Netherlands, New Zealand, North Macedonia, Romania, South Africa, Spain, Turkey, United States

Administrative Information

• NCT Number: NCT05888844
• Other Study ID Numbers: INCB 99280-212; 2022-502476-23-00 ( Registry Identifier: EU CT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• URL: https://www.incyte.com/our-company/compliance-and-transparency

• Current Responsible Party: Incyte Corporation
• Original Responsible Party: Same as current
• Current Study Sponsor: Incyte Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Incyte Medical Monitor; Incyte Corporation

• PRS Account: Incyte Corporation
• Verification Date: May 2024